When we were still (relatively) young lawyers, we defended Bendectin cases. There was nothing wrong with Bendectin – the litigation produced Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court’s landmark decision on excluding bogus expert testimony, and numerous other decisions, state and federal, excluding “junk science.” Nonetheless, Bendectin’s primary use was as a treatment for morning sickness, and morning sickness occurs at the same time as do many fetal birth defects. The incessant litigation drove Bendectin off the market – the FDA did not remove it.
For example, according to [one] defendant . . ., Bendectin, the only antinauseant drug available for pregnant women, was withdrawn from sale in 1983 because the cost of insurance almost equalled the entire income from sale of the drug. Before it was withdrawn, the price of Bendectin increased by over 300 percent.
Brown v. Superior Court, 751 P.2d 470, 479 (Cal. 1988). The destructive power of Bendectin litigation also brought into currency the terms “tortogen” and “litigen,” both meaning products that generated litigation, but didn’t actually cause anything. See R.L. Brent, “Bendectin: Review of the Medical Literature of a Comprehensively Studied Human Nonteratogen & the Most Prevalent Tortogen-Litigen,” 9(4) Reprod. Toxicol. 337 (July-Aug. 1995) (available here for $$$). Because Bendectin was the only medication approved to treat this morning sickness, pregnant women with morning sickness were left with no FDA-approved therapeutic alternative.
We also worked on vaccine cases, mostly DPT, and but for Congress stepping in with the Vaccine Act – successful preempting just about all product liability litigation against essential vaccines – plaintiffs were on the verge of driving those products off the market as well:
But in the 1970’s and 1980’s vaccines became, one might say, victims of their own success. They had been so effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases, and much more concerned with the risk of injury from the vaccines themselves.
. . . This led to a massive increase in vaccine-related tort litigation. Whereas between 1978 and 1981 only nine products-liability suits were filed against DTP manufacturers, by the mid-1980’s the suits numbered more than 200 each year. This destabilized the DTP vaccine market, causing two of the three domestic manufacturers to withdraw; and the remaining manufacturer . . . estimated that its potential tort liability exceeded its annual sales by a factor of 200. Vaccine shortages arose when [it] had production problems in 1984.
Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226-27 (2011) (footnotes omitted).
But we haven’t looked at this issue recently – and never on the blog − so we thought we’d see what all this litigation, particularly the explosion of attorney-solicited MDL litigation, has affected targeted products. Put the emphasis on “recently,” because we’re not citing any material prior to 2000 for the rest of this post. For some older examples (other than those above). See Paula Jacobi, “Pharmaceutical Tort Liability: A Justifiable Nemesis to Drug Innovation and Access?,” 38 J. Marshall L. Rev. 987, 991-93 (2005) (the “other casualties” section).
We’ve already discussed the impact of product liability litigation on reproductive choice, since seemingly every contraceptive that’s come on the market has been the target of one mass tort or another. We’re not the only ones either.
[P]laintiff attorneys − perhaps inspired by the litigation surrounding silicone breast implants − targeted [the] contraceptive Norplant, a hormonal preparation encapsulated in a silicone elastomer. This was despite the FDA having no concerns over the drug’s safety. During more than five years in court, the manufacturer won three jury verdicts, 20 pretrial judgments and dismissal of some 14,000 claims. A trial verdict against the manufacturer was overturned on appeal. Despite the favourable rulings, defending the product was a significant financial burden.
Jerome Strauss III & Michael Kafrissen, “Waiting for the Second Coming: Contraceptive Research Is Seriously in Need of Revitalization, 432 Nature 43 (2004).
Pharmaceutical companies have moved out of contraceptive research because of fear of product liability lawsuits and particularly the enormous and seemingly standardless sums juries have awarded in punitive damages in such litigation. . . . Why have pharmaceutical companies moved out of contraceptive research? Why wouldn’t they? Nothing jeopardizes corporate profits like controversy over a contraceptive, which, in turn, can discourage the development of new contraceptives.
William Brown, “Déjà Vu All over Again: The Exodus from Contraceptive Research and How To Reverse It, 40 Brandeis L.J. 1, 32-34 (2001) (footnotes omitted). See Linda Johnson, “Wyeth Says Norplant Will Stay Off The Market. The Company Made Its Decision Despite Tests That Backed Up the Effectiveness of the Birth-Control Implants.”, 2002 WLNR 2853999 (Phila. Inq’r. July 27, 2002).
And it is indeed “déjà vu all over again. We could make a good additional example of the Essure contraceptive system, but for the time being our first obligation to our clients precludes us from doing that in this post.
Apparently, vaccines aren’t out of the woods, yet either. “Developers have faced an uphill battle since LYMErix, a short-lived human vaccine, was pulled from the market in 2002 amid low demand and lawsuits over potential side effects.” Brittany Flaherty, “Can a New Lyme Disease Vaccine Overcome a History Of Distrust and Failure?” Health STAT (Aug. 22, 2019).
The vaccine, Lymerix, had caused controversy in recent years, as patients said they were sickened by it and asked the government to restrict sales. Some filed lawsuits against the maker.
“Sole Lyme Vaccine Is Pulled Off Market” (N.Y. Times Feb. 28, 2002). Thus, “in the face of lawsuits and plummeting demand triggered by the resulting adverse publicity, the manufacturer of [that] vaccine against . . . decided to withdraw its FDA-approved product from the market.” Lars Noah, “Triage in the Nation’s Medicine Cabinet: The Puzzling Scarcity of Vaccines and Other Drugs,” 54 S.C. L. Rev. 371, 392 (2002) (footnote omitted).
Another litigation casualty was Accutane, a last resort treatment for serious acne. Yes, it was teratogenic, so Accutane had detailed warnings and a contraindication for pregnant women. Those warnings were repeatedly found adequate as a matter of law. E.g., Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 105 (Fla. 1989); Banner v. Hoffmann-La Roche, Inc., 891 A.2d 1229, 1237 (N.J. Super. App. Div. 2006); Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 817 (5th Cir. 1992) (applying Mississippi law); Bealer v. Hoffman-La Roche, Inc., 729 F. Supp. 43, 45 (E.D. La. 1990). No, the problem was widespread bogus litigation involving intestinal problems. Federal claims got the Daubert boot early on, see In re Accutane Products Liability, 511 F. Supp. 2d 1288, 1303 (M.D. Fla. 2007) (plaintiffs’ experts’ “testimony does not satisfy the requirements of Daubert or Federal Rule of Evidence 702”), but mass tort litigation persisted for years in New Jersey before that state’s Supreme Court finally affirmed that the scientific basis for such claims was non-existent:
In sum, the trial court explained its reasons for concluding that plaintiffs’ experts deviated from core scientific principles and strayed from their own claimed methodology in order to reach their conclusions. That the trial court deemed their testimony to be unreliable and excluded it from being presented is unsurprising. Ample evidence in the record supports that conclusion.
In re Accutane Litigation, 191 A.3d 560, 593 (N.J. 2018). 2018 was too late for Accutane as a litigen, however. It had been removed from the market in 2009 as unprofitable due to the combined effects of generic competition and litigation:
[The manufacturer] said the move was not done for safety or efficacy reasons and was unlikely to have any impact on earnings. . . . The [manufacturer] noted on Friday it has been faced with high costs from personal injury lawsuits that it continues to defend against vigorously.
“Roche stops selling acne drug Accutane,” Reuters (June 26, 2009).
Liability concerns are also a primary reason why “Right to Try” initiatives, including a federal statute we critiqued here, have been generally unsuccessful in making investigational drugs available to terminally ill patients.
[E]ven if drug manufacturers offer INDs [investigational new drugs] after the drugs have met the FDA’s safety standards to initiate phase II trials, the drug manufacturers may still be liable for the injuries that result from the INDs. . . . Given the likelihood of tort liability under this framework, it is unlikely a manufacturer would willingly provide patients with unapproved medications without a statutory shield from liability.
Andrew Zacher, “False Hope & Toxic Effects: Proposed Changes to the FDA Drug Approval Process Would Fail to Benefit the Terminally Ill,” 14 Quinnipiac Health L.J. 251, 278-79 (2011) (footnotes omitted).
Finally, we would be remiss not to include the ongoing threat to product research and innovation generally posed by “innovator liability” − the bizarre theory that, because of preemption, innovator/branded drug manufacturers should be liable for injuries caused by competing generic drugs. The suppressive effect that such massive liability (generics account for around 90% of current prescriptions) on the ability of companies to dedicate the vast sums necessary establish the safety and effectiveness of new drugs has been widely acknowledged. See McNair v. Johnson & Johnson, 818 S.E.2d 852, 866 (W. Va. 2018) (“significant litigation costs would be added to the price of new drugs” and “the increase in litigation against brand manufacturers could stifle the development of new drugs, which would have negative health consequences for society”); Huck v. Wyeth, Inc., 850 N.W.2d 353, 377 (Iowa 2014) (“extending liability to brand manufacturers for harm caused by generic competitors would discourage investments necessary to develop new, beneficial drugs by increasing the downside risks”); In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 944 (6th Cir. 2014) (“there are grave health policy consequences associated with recognizing brand manufacturer liability in these situations including higher priced brand name drugs and fewer innovative drugs”); Rossi v. Hoffmann-LaRoche, 2007 WL 7632318 (N.J. Super Law Div. Jan. 3, 2007) (innovator liability “could only act to stigmatize the ability of companies to develop new and innovative drugs”); Anna Laakmann, “The Hatch-Waxman Act’s Side Effects: Precautions for Biosimilars,” 47 Loyola L.A. L. Rev. 917, 926 (2014) (innovator liability “could further dampen the incentives to create new drugs and thus reduce overall patient welfare”); Lars Noah, “Adding Insult to Injury: Paying for Harms Caused by a Competitor’s Copycat Product,” 45 Tort Trial & Ins. Prac. L.J. 673, 688-89 n.69 (2010) (innovator liability “threatens to chill therapeutic product innovation”); Victor Schwartz, et al., “Warning: Shifting Liability to Manufacturers of Brand-Name Medicines When the Harm Was Allegedly Caused by Generic Drugs Has Severe Side Effects,” 81 Fordham L. Rev. 1835, 1871 (2013) (innovator liability makes it “riskier for brand-name manufacturers to dedicate resources to researching and developing potentially life-saving or life-improving medicines”); Samantha Koopman, “Hidden Risks of Taking Generic Drugs over Brand Name: The Impact of Drug Labeling Regulations on Injured Consumers & the Pharmaceutical Industry,” 34 J. Nat’l Ass’n Admin. L. Judiciary 112, 140 (2014) (“Overall, innovator liability likely results in less new drug development.”).
Thus, commentators widely recognize that “[t]ort litigation has also been shown to inhibit drug development and drive some drugs off the market.” Erika Lietzan & Sarah Pitlyk, “Thoughts on Preemption in the Wake of the Levine Decision,” 13 J. Health Care L. & Pol’y 225, 255 n.167 (2010). “[P]harmaceutical companies will simply not make choices in support of research, manufacture and marketing of low-margin, high-liability risk drugs.” Jacobi, “Justifiable Nemesis,” 38 J. Marshall L. Rev. at 1009. “[S]hortages of vaccines and other critical pharmaceutical products have increased in the last few years” due to “[p]ressures emanating from regulatory agencies, courts, and insurers,” which have “ma[d]e this line of the pharmaceutical business less than attractive.” Noah, “Triage,” 54 S.C. L. Rev. at 402.
One final irony: Plaintiffs cannot bring claims that products marketed with the FDA’s blessing should be removed from the market. For relatively obvious reasons, when the FDA has said “yes,” plaintiffs can’t (under the Supremacy Clause) claim that state law says “no.” E.g., Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 488 (2013) (“We reject this ‘stop-selling’ rationale as incompatible with our pre-emption jurisprudence.”). Yet, in the examples we’ve cited, plaintiffs have often accomplished the same thing – simply by using the time, expense, and liability threat of mass litigation to make continued sales uneconomic. As long as plaintiffs are able to uses these inefficiencies of modern litigation as a weapon to deter drug marketing, regardless of what the FDA has found, society will continue to be deprived of prescription medical products that the FDA’s evaluation of safety and effectiveness would have allowed on the market.